RECALL NOTICE: Baby Bum Mineral SPF50
URGENT MEDICINE RECALL
(TGA Recall Reference Number: RC-2022-RN-00625-1)
Baby Bum® Mineral SPF50+ Lotion, 88mL, AUST L 355134,
LOT# N1118B and LOT# N1118C, EXP 04/2024
Sun Bum Pty Ltd (Sun Bum), after consultation with the Therapeutic Goods Administration (TGA), has decided to conduct a Class II consumer level recall of one discrete batch of Baby Bum® Mineral SPF50+ Lotion 88mL, AUST L 355134 (Product Code 37-50350), being LOT# N1118B and LOT# N1118C manufactured on 28 April 2021 with expiration date of 04/2024 (Affected Product).
We are contacting you as the specific batch of potentially Affected Product may have been supplied to your organisation.
This recall does not affect any Sun Bum® products or any other Baby Bum® products.
Sun Bum has identified one discrete batch of the Affected Product (Baby Bum® Mineral SPF50+ Lotion, AUST L 355134, LOT# N1118B and LOT# N1118C manufactured on 28 April 2021 with expiration date of 04/2024) that has been supplied in Australia since 1 August 2021 that potentially contains above the allowable amount of benzene. It is not an ingredient in this product and the source is likely contamination as it is sometimes used in medicine manufacturing processes and raw materials in very low levels.
The TGA has conservative limits on these types of solvents and benzene must be below a concentration of 2mg/kg or 2 parts per million (ppm) in medicines. Because sunscreen products are listed as medicines in Australia, the TGA has confirmed that this limit applies. Benzene is classified as a human carcinogen, a substance that could potentially cause cancer, depending on the level and extent of exposure.
A recent test of the product detected benzene at a concentration of around 2.4 ppm in the two lots of the Affected Product supplied in Australia. Exposure to benzene in this sunscreen lotion product, at the levels detected and in a lotion form designed for topical application rather than an aerosol product, is considered to have extremely low health risk to the consumers who may have used these products. TGA guidelines for this matter are set to ensure that an individual’s excess cancer risk does not exceed 1 in 100,000 if that individual used the maximum recommended amount of the product every day for 70 years. However, out of an abundance of caution and to reduce the risk to consumers, Sun Bum has made the decision to recall the Affected Product supplied in Australia.
Sun Bum is actively working with the TGA to facilitate this recall and is also working to ensure that this issue does not occur with this product or any other products in the future. Sun Bum has established recall websites for customers and consumers to provide a reliable and easily accessible source of information regarding the recall and to ensure the smooth implementation of consumer resolution. One website is the Baby Bum Recall Retailer Website for trade customers like you, which provides general information about the recall and tells you what you need to do to help us manage the recall. You can find this at https://www.babybumrecallanzretailer.com. The other website is for consumers, which sets out the process they need to follow to seek a refund and tells them to discard Affected Product.
As stated earlier, this recall does not affect any Sun Bum® products or any other Baby Bum® products.
RECALL NOTICE: FRIGG
FRIGG Production ApS are recalling all SILICONE FRIGG pacifiers.
FRIGG Production ApS has experienced a fault on a few SILICONE FRIGG pacifiers, where the nipple partly detaches from the pacifier shield.
There is a risk that the nipple will completely detach and thereby pose a possible danger to the child.
ALL SILICONE pacifiers, sold between 01-04-2021 and 10-12-2021. Retailers and shops have been instructed to terminate sales of the pacifiers.
WHAT TO DO
If you have any SILICONE FRIGG pacifiers, please remove it from your child, dispose them or return it where you purchased it.
FRIGG Production ApS has a very strong focus on product safety and quality and have therefore stopped production and are currently reengineering the design before releasing the SILICONE FRIGG pacifiers again.
Sorry for the inconvenience
FRIGG Production ApS